An interventional study of Telerehabilitation and Standard Care in Breast Neoplasms, sponsored by Fondazione Policlinico Universitario Campus Bio-Medico. Recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Fondazione Policlinico Universitario Campus Bio-Medico · Not applicable, Interventional, and Treatment
The most common complaints after breast surgery are postoperative pain reported in up to 68% of patients, musculoskeletal problems in the shoulder and functional limitations in up to 59% of patients after mastectomy and quadrantectomy, reduction in range of motion ( ROM) in 24-53% and strength deficit.
The study aims to verify the effectiveness of a telerehabilitation treatment in terms of prevention of possible complications following breast cancer surgery.
Primary objective: to examine whether the group of patients undergoing rehabilitation surgery in the immediate post-operative period shows a reduction in the onset of complications compared to the group of patients who followed standard procedures.
Secondary objective: to study any preoperative prognostic factors for the onset of complications, to study the effectiveness of the rehabilitation treatment in terms of reduction of painful symptoms, improvement of joint ROM, muscle strength and perceived quality of life.
Breast cancer is the most common malignancy in women worldwide. Advances in early detection and improved treatment of breast cancer have led to increased survival after diagnosis, resulting in many more women living with the consequences of cancer treatment.
Breast cancer surgeries and treatments can cause arm morbidity that can progress beyond 2.5 years.
The most common complaints after breast surgery are postoperative pain reported in up to 68% of patients, musculoskeletal problems in the shoulder and functional limitations in up to 59% of patients after mastectomy and quadrantectomy, reduction in range of motion ( ROM) in 24-53% and strength deficit.
Other complications include postoperative axillary web syndrome (AWS), which can cause pain and movement limitations; lymphedema reported with a prevalence of 6-52% especially after axillary lymph node dissection (ALND); kinematic alterations that may promote future development of rotator cuff disease; scapulohumeral dyskinesia, proprioception deficit, postural alterations and reduced quality of life.
There is scientific evidence in the literature to suggest that early postoperative exercise is safe and can improve shoulder function; however, uncertainty remains about the optimal content, timing, and cost-effectiveness of exercise interventions.
The study aims to verify the effectiveness of a rehabilitation treatment in terms of prevention of possible complications following breast cancer surgery.
Primary objective: to examine whether the group of patients undergoing rehabilitation surgery in the immediate post-operative period shows a reduction in the onset of complications compared to the group of patients who followed standard procedures.
Secondary objective: to study any preoperative prognostic factors for the onset of complications, to study the effectiveness of the rehabilitation treatment in terms of reduction of painful symptoms, improvement of joint ROM, muscle strength and perceived quality of life.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 155 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fondazione Policlinico Universitario Campus Bio-Medico is the lead sponsor of 29 studies on the registry; 20 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the days following surgery, intervention group will receive a structured rehabilitation session by a physiotherapist. In this session, two booklets will be provided to the patients, with the aim of informing and educating, regarding the most frequent complications after breast cancer surgery and how to avoid their possible onset through the demonstration of exercises to be carried out at home, self-massage techniques of the scar, behaviors and lifestyle to be adopted immediately after surgery. This group will carry out, starting from 10 days post-surgery, a home tele-rehabilitation intervention from Monday to Friday via the TeleHab device (Vald Performance) until 2 months after surgery. Exercises for ROM recovery and strength recovery will be carried out three days a week and only exercises for ROM recovery will be carried out two days a week.
Other: Telerehabilitation
Standard care consists of the usual treatment according to current clinical practice, no structured physiotherapeutic interventions will be carried out which generally consists of the delivery of two booklets, with the aim of informing and educating, regarding the most frequent complications after breast cancer surgery and how to avoid its possible onset through the demonstration of exercises to be carried out at home, self-massage techniques for the scar, behaviors and lifestyle to be adopted immediately after surgery.
Other: Standard Care
The telerehabilitation intervention will begin from 10 days post-surgery, the operation will be carried out at home from Monday to Friday via the TeleHab device (Vald Performance) up to 2 months after the surgery. Exercises for ROM recovery and strength recovery will be carried out three days a week and only exercises for ROM recovery will be carried out two days a week. The progression of the exercises will be carried out taking into account the pain and fatigue recorded by the patient at the end of each exercise session.
Standard care intervention follow the usual treatment according to current clinical practice, no structured physiotherapeutic interventions will be carried out. It consists of the delivery of two booklets, with the aim of informing and educating, regarding the most frequent complications after breast cancer surgery and how to avoid its possible onset through the demonstration of exercises to be carried out at home, self-massage techniques for the scar, behaviors and lifestyle to be adopted immediately after surgery.
Complications
Number of complications (i.e. axyllary web syndrome; lymphedema; persistent pain)
Time frame: 7-10 days after surgery
Complications
Number of complications (i.e. axyllary web syndrome; lymphedema)
Time frame: 2 months after surgery
Complications
Number of complications (i.e. axyllary web syndrome; lymphedema)
Time frame: 6 months after surgery
Upper limb pain
Pain assessed through the numeric pain rating scale (0-10)
Time frame: before surgery
Upper limb pain
Pain assessed through the numeric pain rating scale (0-10)
Time frame: 7-10 days after surgery
Upper limb pain
Pain assessed through the numeric pain rating scale (0-10)
Time frame: 2 months after surgery
Upper limb pain
Pain assessed through the numeric pain rating scale (0-10)
Time frame: 6 months after surgery
Neck Disability
Neck related disability assessed through the questionnaire Neck Disabiltiy Index Value range (0% min disability - 100% max disability)
Time frame: before surgery
Neck Disability
Neck related disability assessed through the questionnaire Neck Disability Index Value range (0% min disability - 100% max disability)
Time frame: 7-10 days after surgery
Neck Disability
Neck related disability assessed through the questionnaire Neck Disability Index Value range (0% min disability - 100% max disability)
Time frame: 2 months after surgery
Neck Disability
Neck related disability assessed through the questionnaire Neck Disability Index Value range (0% min disability - 100% max disability)
Time frame: 6 months after surgery
Upperlimb Disability
Upperlimb related disability assessed through the questionnaire Disability of the arm, shoulder and hand (DASH) Value range (0% min disability - 100% max disability)
Time frame: before surgery
Upperlimb Disability
Upperlimb related disability assessed through the questionnaire Disability of the arm, shoulder and hand (DASH) Value range (0% min disability - 100% max disability)
Time frame: 7-10 days after surgery
Upperlimb Disability
Upperlimb related disability assessed through the questionnaire Disability of the arm, shoulder and hand (DASH) Value range (0% min disability - 100% max disability)
Time frame: 2 months after surgery
Upperlimb Disability
Upperlimb related disability assessed through the questionnaire Disability of the arm, shoulder and hand (DASH) Value range (0% min disability - 100% max disability)
Time frame: 6 months after surgery
Self-reported Quality of life
Impact on quality of life assessed through the questionnaire Short Form-36 Health Survey Value range (0 min QoL- 100 max QoL)
Time frame: before surgery
Self-reported Quality of life
Impact on quality of life assessed through the questionnaire Short Form-36 Health Survey Value range (0 min QoL- 100 max QoL)
Time frame: 7-10 days after surgery
Self-reported Quality of life
Impact on quality of life assessed through the questionnaire Short Form-36 Health Survey Value range (0 min QoL- 100 max QoL)
Time frame: 2 months after surgery
Self-reported Quality of life
Impact on quality of life assessed through the questionnaire Short Form-36 Health Survey Value range (0 min QoL- 100 max QoL)
Time frame: 6 months after surgery
Joint range of motion
upper limb and cervical range of motion assessed through digital goniometer
Time frame: before surgery
Joint range of motion
upper limb and cervical range of motion assessed through digital goniometer
Time frame: 7-10 days after surgery
Joint range of motion
upper limb and cervical range of motion assessed through digital goniometer
Time frame: 2 months after surgery
Joint range of motion
upper limb and cervical range of motion assessed through digital goniometer
Time frame: 6 months after surgery
Muscle strength
handgrip, shoulder and neck muscle strength assessed through handheld dynamometer
Time frame: before surgery
Muscle strength
handgrip, shoulder and neck muscle strength assessed through handheld dynamometer
Time frame: 7-10 days after surgery
Muscle strength
handgrip, shoulder and neck muscle strength assessed through handheld dynamometer
Time frame: 2 months after surgery
Muscle strength
handgrip, shoulder and neck muscle strength assessed through handheld dynamometer
Time frame: 6 months after surgery
Plan to share: No
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for May 2026, 36 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 36 months is close to that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
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Fondazione Policlinico Universitario Campus Bio-Medico